Zdrowie i gospodarka · 21/08/2025
FDA Classifies Anti-Phospholipase A2 Receptor Immunological Test System into Class II
The FDA is classifying the anti-phospholipase A2 receptor immunological test system into Class II, a move aimed at ensuring the device's safety and effectiveness while reducing regulatory burdens and enhancing patient access.
Source: Federal Register — Food and Drug AdministrationOpen original release →